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Hoosier State Today

Tuesday, November 5, 2024

Indiana: Devices companies were the second most FDA inspected companies in Indiana in December 2023

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

In December 2023, two Devices companies received two FDA inspections in Indiana, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Indiana, equalling 28.6% of all inspections in December 2023.

Of all the Indiana companies involved in Devices, Single Source Medical, LLC. received the most citations from the FDA in December 2023.

The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.

The FDA is a government agency primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

FDA inspections in Indiana during December 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products1----
Colors and Cosmetics Technology1----
Compliance: Devices--2--
Foodborne Biological Hazards3----
Monitoring of Marketed Animal Drugs, Feed, and Devices--1--
Postmarket Assurance: Devices2----

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